At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
Tolvaptandrug
Likely dose
Tolvaptan 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-labeled, Dose-defining Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
In Brief
A Phase 3 clinical trial evaluating Tolvaptan for Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload. Completed, enrolled 60 participants across 1 site.
Detailed Summary
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartMar 2018
Primary CompletionJul 2021
Study CompletionJul 2021
TodayJul 2026
First PostedAug 21, 2017
Enrollment StartMar 7, 2018
Primary CompletionJul 11, 2021
Study CompletionJul 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.9 years ago
Interventions
Tolvaptandrug
Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.